CZ140192A3

CZ140192A3 - Two-part genital receptacle and a connecting ring therefor

Info

Publication number: CZ140192A3
Application number: CS921401A
Authority: CZ
Inventors: Michael R Lavender
Original assignee: Hollister Inc
Priority date: 1991-06-21
Filing date: 1992-05-11
Publication date: 1993-01-13
Also published as: HU9201053D0; HK159396A; PL294269A1; DE69211427T2; EP0519586A1; ES2087449T3; NO179062C; IE75730B1; AU1392492A; EP0519586B1; ATE139111T1; DE69211427D1; NO179062B; PL169941B1; FI921333A; JPH06285104A; HUT67401A; JP2515466B2; NO921188D0; AR246423A1

Abstract

A two-piece ostomy appliance having a pair of coupling rings that detachably connect a collection pouch and an adhesive faceplate. One of the coupling rings, preferably the faceplate coupling ring (14), is provided with a substantially non-compressible insert (14, 16) that includes an axially-extending collar (35), a bulbous non-deformable wedge body (36), and a radially-extending pivot stem (37) that centrally connects the collar and wedge body. The pivot stem allows limited forward and rearward rocking movement of the wedge body about a pivot axis extending through the stem. A massive front portion of the wedge body has an inwardly and rearwardly curved bearing surface of progressively increasing distance from the pivot axis so that the radial width of the insert decreases as the wedge body rocks rearwardly and forceably increases as it rocks forwardly about the axis, in response to frictional engagement with the walls of the channel, when coupling and uncoupling forces are exerted on the rings. <IMAGE>

Description

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to two-part ostomy devices comprising, on the one hand, a collecting bag and an adhesive pad with an opening for attachment to a patient's mouth, the two parts being detachably connected to each other by connecting rings.

Background Art

One widely available two-part ostomy device (Hollister two-piece ostomy system) includes a collection bag with a connecting ring defining a channel arranged around the opening in the wall of the bag, and a sticky attachment plate provided with a corresponding ring with a compressible liner inserted into the channel. The insert portion includes a relatively thick and rigid annular member having a tapered deformable wiper flange that " is tilted backward and away from the front icon 'of the annular member for resilient and tight engagement in one of the channel walls when the parts are connected to each other. The opposite channel wall is provided with at least one projection capable of engagement with the opposite projection extending from the side of the annular member against the deformable wiper flange. Since the width of the insert in the incompressible state is greater than the width of the channel, the insertion of the connecting rings into one another simultaneously engages the side of the annular member with the projection and fluid-tight connection to the side of the flange wiper.

In order to ensure a reliable fluid-tight connection of the rings, both the compressible insert with its flange flange and the channel walls are deformed when the portions are wiped, the flange r is bent in the direction of the annular ring. at the same time as the side walls of the channel extend apart from each other.

litsměrem ven ^ tak,! <;.'that | -se, rtyto | ^' ^ y / 'rožbíha jíý ^ m ^ B ^^^ e ^ \ t

r.rrxv Λ into the channel. One consequence of such interaction and divergence of the channel walls is that the tightness of the non-part joining will gradually decrease whenever the flake moves toward the channel inlet. Since the tension and deformation of both the channel and the flexible wiper flanges are reduced, the safety of the locking and sealing of the joint is impaired.

Another feature of such a two-piece design is that if the connecting rings are sized to provide a closer fit to provide greater reliability against the random separation of the rings, the effort required to join the rings together will also increase. Therefore, the reliability of the connection is attained on account of the requirement for substantial deformation of the parts during assembly, such deformation requiring the development of a substantial bonding force, so that some users, of course, "

Podstatayvynálezú

The present invention relates to a collection bag and a sticky plate. a means for attaching around the patient's mouth, wherein the pouch is provided with an opening for attachment to the mouth and a first attachment ring attached thereto about said opening, said aperture being attached thereto; The filamentary ring has a pair of concentric side walls spaced apart from each other, and the connecting wall can be folded to extend the expandable ring channel of the inverted ring. axial direction " away from said bag, the second attachment ring having an insert liner can be retracted "" the said expansion channel having a gripping engagement with said ring, the improvement being that said annular recess means is substantially incompressible and resides in a frictional engagement with both side walls; the insert means comprises an axially oriented annular sleeve, an onion non-deformable annular body, an annular radially extending swivel shaft connecting said non-deforming body and the annular sleeve in a concentric relationship, said body comprising a forward portion extending forwardly beyond said stem and a rear portion extending rearwardly of said stem, wherein both said rear and said front portions are radially spaced from said sleeve, said stem supporting said body for limited height; swinging forward and backward about the pivot axis in said shank, said front of said body having a rearwardly curved engagement surface with a gradually increasing distance from said pivot axis, thereby reducing the width of said incompressible insert when said non-deformable body is pivoted to the rear, and increases when said body is pivoted forward about said axis of rotation, due to frictional engagement with the wall of said channel when corresponding connecting and disconnecting forces are exerted on said ring.

The main advantage of the invention is that it forms a two-part ostomy device with connecting rings that provide a high level of reliability when inserted, but still require little effort for the user to join. High reliability is achieved due to the expandable swiveling action of the non-deformable wedge body that occurs during the initial stages of ring separation. Such a pivoting movement effectively increases the radial width of the substantially incompressible insert and thereby increases the resistance to ring separation. At the same time, the ease of assembly is enhanced, since the opposite rotation of the non-deformable wedge body reduces the effective effective width of the insert during the connection, thereby reducing channel deformation and reducing the force required to push the insert into the channel. These results and differences in their operation resulting from their solution can be achieved by replacing only the retractable connecting ring (ie, the " insert plate ring ") of the present invention with a flexible one. -4- ring of divine, two-part system described above. The standard channel-forming ring (for example, the bag ring) of the knife remains unchanged, although it may be desirable to have a ring.

In contrast to the prior art coupling plate rings, the inventive ring has an annular insert that is substantially non-compressible in radial directions and includes an axially oriented annular sleeve, an onion-shaped non-deformable wedge-shaped ring and annular, radially extending and a swivel shank having shapes as detailed above. Due to the progressively increasing radii of curvature of the engagement surface towards the rear and the formation of a shank that supports the wedge body with limited swinging possibility. around the axis of rotation, the massive non-deformable body acts as a swivel wedge that forcibly increases the radial width of the incompressible liner when the wedge body swings forward, and decreases this width as the wedge swings backwards. Swiveling rearwardly during insertion and pivoting forwards while pulling out so that the locking action automatically increases creates self-adjusting to increase coupling forces during assembly while providing for forced stretching and desirable increased resistance to random part separation when fully coupled.

According to another particular feature of the invention, the curved engagement surface extends rearwardly of said front portion and terminates in a contact edge for concentrating force along said rear portion. The curved engagement surface of said front portion may also terminate the bull at the rear end of said forward portion on a contact edge for concentrating the force radially disposed with said pivot shaft when said engagement ring is tension free.

The wedge body may be provided with a step on said contact edge, and the tactile play may be adapted to engage the surface of one of said sidewalls. .w £ :: • 'í ·: φ:,. ·,; Μ * ?, ý5§. - i

-7νΤ- ~ ν7 ~ ^ Γ— ~ T _ e; _ e; walls in the channel. Said surface is said to be one side of the wall of the wall and be smooth and flat in the ground: the smoke is not expanded. Similarly, the aforementioned step may not be delimited by surfaces at right angles at the base. According to a further feature of the invention, the new body is supported by said pivoting stem. for a height range of about 2 dc about 20 degrees around said axis of rotation. The maximum radial damper of said wedge body may substantially exceed the maximum radial thickness of said sleeve and optionally may extend beyond the combined maximum radial thickness of said sleeve and said shank.

According to a further feature of the invention, said wedge body is mounted radially within said sleeve.

Said sleeve, swivel stem and swivel wedge / body may be integrally formed of semi-rigid plastic.

The invention further relates to a connecting ring for a two-part ostomy device, wherein the ring comprises in a substantially incompressible insert means 5 for insertion into the V ' · 'In " the axial passage of the corresponding connecting ring, wherein said insert means comprises an axially oriented annular sleeve, an onion-like non-deformable annular-shaped body and an annular swiveling shaft connecting said body and the sleeve in a radially spaced concentric arrangement; wherein said onion body comprises a forward portion extending forwardly beyond said shank and a rear portion extending beyond said shank, said shank supporting said body for limited forward and backward movement about an axis of rotation, and said front portion of said body having a "rearwardly curved engagement surface" with gradually! ".The increasing distance from the specified axis of rotation,

Said engaging surface of the coupling

The present invention according to another feature extends rearwardly with a contact edge for concentrating a portion of said rear portion. Similarly, according to another feature, the knife has a curved engagement surface terminating at the rear end of said front portion on a contacting edge for concentrating the force disposed with said shank when said second connecting ring of paradise is not energized.

A step can be formed on said contact edge by said wedge body. This step can be defined by substantially angular surfaces.

According to a further feature of the connecting ring according to the invention, said wedge body can be supported by said pivoting pin for pivoting movement in the range of about 2 to 20 degrees · about said axis.

According to a further feature of the connecting ring according to the invention, the maximum radial thickness of said wedge body can substantially exceed the maximum radial thickness of said sleeve, or exceed the combined maximum radial thickness of said sleeve.

The wedge-shaped body may be disposed radially inside said sleeve, said sleeve having a pivoting stem and a swiveling wedge-shaped body are preferably integrally formed of semi-rigid plastic. mass. '...... BRIEF DESCRIPTION OF THE DRAWINGS

BRIEF DESCRIPTION OF THE DRAWINGS The invention is explained in more detail in the following description with reference to the accompanying drawings, in which: FIG. 1 is a vertical section through an inventive device showing a disengaged state, FIG. 2 is an enlarged perspective view of the coupled connection ring, with partial separation of some of the portions to illustrate the cut shapes of the components of FIG. 3, a large sectional enlargement of the connecting ring of the insert showing the extent of the pivoting " wedge body " Fig. 4 to Figures, 'schematic sectional' details showing the rings in a separate state (Fig. 4) and in a fully assembled state (Fig. 5) and 'V' showing keying, " which arise during the -7-7-enlargement stages of ring separation (Fig. 6), Fig. 7 similar to Fig. 3, but showing a second. O Lt OU i O jo no s1 ,, 1 ,. í · ,, ΐ > .ιι - α ώ. c * j a. j, sp appendage '- «' i - 'V > - -7 3 ~ - · Λ. Fig. 9 is a view similar to Fig. 8, but showing the automatic pivoting and wedge action that occurs when axial forces are exerted on the bag; start separating the two rings.

An embodiment of the present invention is a cstomic attachment collection bag 11a

FIGS. 1 to 6 show a two-part means 10, one part of which is formed by the first connecting ring 12, and the other is provided with a supporting plate 13 provided with a second connecting ring 14. of the type manufactured and supplied by Hollister Corporation, Libertyville, Illinois, for interacting with a connecting ring of an insert of a completely different design and operation than the illustrated ring 14. Some features of the illustrated pouch 12 may be unnecessary or may have a reduced significance in context. The pouch 11 is formed of two sheets 11a, 11b of thermoplastic material thermally bonded along their edges 15. The pouch may be provided with a discharge outlet at its lower end, which may be closable by a suitable clamping means (not shown) such as described in the patent patent. No. 3,523,543, or may be sealed at its lower end, thereby rendering the pouch unsuitable. One bag wall 11a has a lateral opening 16 with a first connecting ring 12, concentrically thermally connected at the joint 17 to the outer surface of the bag wall 11a around the opening.

The bag ring 12 has a cross-sectional shape of a channel with a pair of inner and outer side walls 18 and 19 interconnected by a connecting wall 20. " The annular channel defined by the ring 12 faces axially away from the pouch 11. The ring opening 22 fits with the mouth opening 16 of the bag. Inner surface '···'

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The inner wall of the channel 13 is smooth and substantially cylindrical (when the ring 12 is in a non-tensioned condition as shown in FIG. 1). and one or more annular ribs 23, 24 may be formed along the opposite outer wall 19 of the formation C. If desired, the outer wall may also be provided with outwardly extending lugs 21 with an opening for attachment to a suitable belt for additional security as known in the art. " Further, a protrusion 21 extends from the outer wall 19 (FIG. 2) to assist the user in disengaging the rings when removal of the bag is desired.

In addition to the distinguishing second connecting ring 14, a plate 13 of known construction is provided. The loading pad can '" contain " a highly flexible flat or plate 2Z preferably formed of a microporous material permeable to gas but resistant to water. Various materials having such properties can be used. The flat structure is provided with its backside or backside adhesive with pressure-tolerant and physically sensitive properties schematically indicated by the dashed line 2Ů so that the insert can be adhered to the skin around the patient's orifice.

The plate 27 ' is provided with a small central opening 29 which serves "" the starting hole into which the user can insert the scissor blade ?; to cut a hole in the loading plate to such a size and contour to fit the patient's orifice. Alternatively, the article provided to the user may be provided with a fabricated orifice having an opening. The coulter 14 can be attached to the plate 13 in a suitable manner. A preferred construction is shown in FIG. 1 where: a thin and pliable annular wall? 30 " * closely '^ appended along " your outer circumference to the ring '14. either its inner circumference to the highly rigid ring-shaped rings 31 ' thermoplastic mate- rial. The intermediate ring itself is thermally coupled along its "inner" larger centers of heat-coupled regions 32 and 33 to the micro-porous plate 1, 27. It is possible to provide details of such a structure and advantage. to refer to the patent specification All the advantages described are described, c CJ Λ 410 4 410 100 and 4 21 3 3 53 t; entrant. : třeb; } knows not to. that though the " floating flange " U.S. Pat. No. 4,410,000 has substantial when used with two-part bars, the fits may be less important when used with a two-part system having a different connecting ring 14 as shown and described herein. Thus, in the construction shown and described herein, the discharge of the wall 30 and the direct connection of the ring 14 to the plate 13 (or the intermediate ring 31) may be less important than when such changes are made in a more conventional two-piece connecting ring system.

2 and 3, the connecting ring 14 is formed integrally with the semi-rigid thermoplastic material, such as low density polyethylene, which is a material that can also be used for bag 12:. The insert plate ring includes a planar, radially oriented flange portion 14a and an axially oriented insert portion 14b. The back side is joined by a thermal bond 34 to the outer ring wall; . 30 and integral from the circular inner circumference * of the flange portion 14a are provided. a wedge-shaped sleeve 35 As is best seen in FIG. 2 " and 3, 'the annular insert portion 14b includes an axially extending apex with a protrusion 35a, an onion non-deformable 36 / annular 4 ''Shank";^'""" Shaped together with collar and wedge-shaped body """

The wedge body 36 comprises a massive forward portion extending forwardly beyond the stem and a similarly massive rearwardly extending rearwardly projecting stem. The relatively large mass of the body 36 is important to make the use of the body substantially non-deformable. So ^^^

Hjsjp. · ·. ' .-t -. > --Λ: i- mwmm 'jL r, l & pjjr. »3fJ |. Is radial thickness * tx sproutTéncfdvifcého wedge'1 *'> .kt. * 'Tífí; The body is much larger than the radial thickness of the sleeve 33, or the pivoting stem 11, or the combined thickness of both the sleeve 33 and the sleeve. and the shank.

The swivel shaft carries a wedge body such that the front portion 36, and the rear portion 36b are disposed radially apart from the sleeve 11. As shown in FIG. 3, the front portion 36a has an inwardly and rearwardly curved engagement surface 31 with a gradually increasing distance from the pivot axis 39 located in the shaft 37. In other words, the radius of curvature of the surface 11 measured by the rotational axis of the swivel 39 increases gradually with the curvature of the surface backward from the front between the front portions 36a ♦ In a particular embodiment shown in Figures 1 to 6, the curved engagement surface 38 continues rearwardly and radially inwardly toward the annular edge 40 along the rearward part 36b. The edge 40 forms the outermost limits of the engagement surface H and the wedge body as a whole.

The edge 4S0 is delimited in part by step 41, and although a sudden change of direction is shown (edge 40 is shown delimited by surfaces that form an approximately right angle), it is believed that the edge or transition delimited by the faces of the smaller or larger blunt may also be suitable. . angle. Although the second edge 42 and the second stage 43 are shown, it is contemplated that such an edge is seldom applied in normal operation and may even be omitted if necessary (see, for example, the embodiment of Figures 7 to 9). Figures 4 to 6 show that the radial width of the insert 14b exceeds the radial width of the channel 21 formed by the connection ring 12 when the ring is in the untensioned condition (Fig. 4). While the semi-rigid plastic material from which the components are made allows the rotating action of the shank, the insert portion 14b as a whole is substantially non-compressible in the radial direction. As the liner portion 14b is pressed into the channel 21 of the bag ring 12, as a result, it must be bent such that its side walls 18 and 19 are pulled outwardly and diverge toward the clay mouth 21a. '' * as 3e known

-11-

Of particular importance is the fact that during such insertion, the arcuate engagement surface 21 of the wedge body 36 contacts the smooth surface 13a of the inner wall 13 and causes the bulbous non-deformable wedge body 36 to rotate rearward (clockwise in FIG. 5) around As the radius of curvature of the engagement surface 21 'measured from the axis of rotation 21' increases rearwardly and decreases forwards, such a pivoting movement of the non-deformable wedge body backwards reduces the actual radial thickness of the insert portion. Consequently, if x represents the radial thickness of the incompressible liner portion 14b when the parts are disengaged (Fig. 4), the radial dimension xy when the rings are fully bonded is significantly less due to the rearward pivoting action of the wedge body 21 (Figs. .5). The effect is that the channel walls 12, 12 are pulled apart by a distance substantially less than would be necessary if the non-deformable wedge body 21 were unable to swing backwards about the axis of rotation passing through the shank 39.

While the insert portion automatically reduces its radial thickness as it enters the channel 21 to restrict the expansion of the channel walls, the opposite effect occurs during extraction. During the initial stages of the ring separation, the frictional contact between the curved engagement surface 38 of the wedge body and the surface 18a of the channel wall 18 causes the wedge body to swing forward about the axis of rotation 39 (FIG. 6). Such forward rotational movement (counter-clockwise as shown by arrows 42 in Figure 6) increases the radial thickness of the non-compressible liner member to x " while pushing the walls 28, 12 further apart thereby increasing the clamping force exerted by these walls on the liner member . Unlike conventional ostomy joints, therefore, the rotational action of the non-compressible liner portion of one ring of the plate wall-second ring extends more or less during ring separation, thereby producing

Despite the relatively high forces required for such random separation, the forces required to join the components to each other are relatively low compared to prior art constructions due to the pivoting movement of the wedge body during insertion backwardly, reducing width.

The extent of oscillation between the extreme cases shown in the drawings may vary considerably depending on facts such as the radius of curved surface J33 and the size of the rings. However, it is generally believed that the extent of such oscillation between the insertion reducing state and the captured and wedged condition is in the range of about 2 to 20 degrees. The forces required for the deliberate separation of the coupling rings are acceptably low despite high resistance to accidental separation. During deliberate removal of the bag, the user typically grabs the tab 26 and pulls it forward from the annulus ring 14, thereby expanding the channel 21 near the protrusion 26, thereby initiating a peeling process that continues in the circumferential direction around the ring until fully separated. The following data are believed to be characteristic of joining and unintentionally detaching the ostomy appliance of the invention as compared to the standard two-part Hollister system currently on the market:

Type 'Channel Extension' Open. Opening. resource when rings are force when force is connected by Oe (safety) 30 "(remove)

Stand. 2 díl.

16.9 N

20.0 N

Hollister 8.75 mm 127.5 N

System by

of the invention 4.0 mm 1,105.3 N

, ~ SV 'ii, V, »1' i *** '% -13- -13- this

Both formulations used in the table use the same bag rings with channels having a width of 3.7 mm in an untensioned (ie, disengaged) state. When the rings of each pair were fully assembled, the width of the bag ring on the standard two-piece Hollister system increased to 3.57 nn, so that the total increment was 0.87 mm (32.4 3;), while for the couplings of the invention the channel width increased to 3.1 mm, so the increment was only 0.4 mm (14.8%). Thus, the expansion of the channel for connection in the invention is less than half that of a standard two-piece Hollister system. Since identical channel rings have been used for both systems, it is believed that a substantial difference in channel expansion between the two cases is a reliable indication that the forces required for joining the connection rings in the present invention are considerably smaller than those required for the standard two-piece Hollister system. The second column shows the forces required to pull the coupler pairs when the rings of each pair are kept parallel to each other (ie, a difference of * tv = zero degrees). 'Resistance to separation under such conditions is considered indicative of resistance to coupling against accidental separation under conditions of use associated with patient body movements, contact with other objects, etc. Standard Hollister's two-part system with 128.5 N is considered to be highly resistant to and the solution according to the invention with 105.3 N also provides a connection with remarkably high safety, especially in terms of its relatively easy assembly. The third column indicates the force required for deliberately detaching the rings when a 30-degree retraction ring is retracted behind the ring projection 26 to start peeling the rings. Although the joining force 20N for the connection of the present invention is higher than "" in the Hollister standard two-part junction (16.9 N), both are considered completely acceptable. Therefore, the information provided indicates '" · -V .: v ·'. >; . ··; No. C; - vv. cv ν '- · v: i; :and. For example, when used with the same type of duct ring for the Hollister two-piece system, the insert plate 11 of the present invention, with its different wedge-shaped wedge, provides a high level of safety against accidental separation, while at the same time requiring less forces to connect these parts together.

The embodiment according to Figs. 7 to 9 is similar to the embodiment described except that the wedge body 36 / has a bearing surface 38 'ending with an edge 40' which is parallel to the pivoting shank 37 (also only a single step 41 '). the shaft 37 * is similar to that described above, and in other respects the connecting ring 14 / is the same as the ring 14 / of the previous embodiment. The swivel wedge 36 is shown in solid lines in Fig. 7 in a non-tensioned state, ie in a state where the rings 14 / and 12 are disengaged. The dashed lines indicate the swivel wedge 36 / in a position that would be expected if the ring 14 / was connected to the ring 12 with the duct as described above. It will be appreciated that when the non-deformable wedge body 36 (rearwardly pivoted about the pivot axis 39) as during insertion of the insert portion 14b 'into the passage 21y, the radial width of the insert portion decreases from χ to χ *. Such a reduction in width occurs irrespective of the fact that the insert portion 14b 'is essentially incompressible. This means that the radial forces parallel to the shank 37 'of the size expected during normal operation of the device would not result in any appreciable reduction in the χ dimension.

When the ring portion 14b 'of the ring 14' is inserted into the channel of the annulus 12 as schematically shown in FIG. 8, the frictional resistance results in the wedge body 36 'rotating rearwardly about the clockwise axis of rotation 39' indicated by the arrow. 47 · The radial / dimension of the insert 14b 'is therefore automatically reduced to χ * when the wedge body 36' swings backwards. As described above, such tilting rearward movement results in less channel widening than would be the case. otherwise needed if non-deformable wedge-shaped body 36. ' it was unable to swing backwards. During the separation of the rings 12 and 14 ', the new telescope 36' swings forward in the direction shown by the arrow 43 in FIG. Since the backward curved engagement surface 33 * has a curvature of successively increasing radii from the pivot axis 391, such forward pivot movement forces the channel wall 18 to move outwardly extending the channel and increases as shown, thereby resisting ring separation. While the operation of the wedge body 36 has been described as rotating about axis 39 ', it will be appreciated that the axis 39 is circular and the wedge body is annular. Since the annular wedge body 36 rotates about axis 31, the front and rear body portions 36a, 36b must alternately expand and contract in the circumferential direction, depending on the direction of such rotation. The extent of such alternating circumferential expansion / contraction is extremely small and the large masses of the wedge body 3j [located upstream and downstream of the axis of rotation (ie, the portions 36a and 36b) resist it, it is believed that the resistance of the massive front and rear portions 36a and 36b to such a change significantly contributes to the effectiveness of the invention. a ring 12 ' having a channel as attached to the bag and a ring 14, 14 ' forming the insert as attached to the insert will be disclosed, but it will be apparent to those skilled in the art that the relationship may be reversed if necessary. for clarity, but either It will be appreciated that such details may be varied without departing from the spirit and scope of the invention.

Claims

6- 6-

Ný Τ Ε Γ Γ n n ο ný ný ný ný ný ný ný ný ný ný ný ný ný ný ný ný ný ný áček áček áček áček áček áček áček áček áček áček áček áček áček áček áček áček áček áček áček áček áček áček the connection around the patient is provided with an aperture for the sealing ring attached to said first attachment pi of the side walls spaced apart and a connecting wall capable of being bent to define an expansion annular channel facing in the axial direction away from said bag, and a second attachment ring having an annular insert means retractable into said extensible channel for sealing and locking engagement with said ring, the improvement being that said annular insert means is substantially incompressible and adapted to frictionally engage both side walls, said insert means including an axially oriented annular sleeve , an onion-like, non-deformable annular-shaped body, and an annular radially extending pivoting stem connecting said non-deformable body and the annular sleeve in a concentric relationship, said body comprising a forward portion extending forwardly beyond said stem and a rear portion extending rearwardly of said stem, wherein both said rear and said front portions are radially spaced from said sleeve, said stem supporting said body for a limited forward and backward pivot movement about the pivot axis of the stem, said front portion of said body having a rearwardly curved engagement surface with progressively increasing clearance from said pivot axis, whereby the width of said incompressible insert means decreases when said non-deformable the body swings backwards, and when said pivot body is forwardly forwarded by said rotational axis, by frictional engagement with the wall of said channel, when said 7 - respond r · “> «*« {“S V * r” S - · cl ·., J. U. j. ---- z. ^.-.- v -., -. rf'1'- - · 'j -. · .. 1- · a. - · - · j; * About tm * Os tom ·? * '· &Gt; · Λ 1-, / - with r · r * s ·' J '-i. L 'L' ·· 'J - · * “od !: by claim”; 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1,. The end of the contact edge is to limit the force along said portion of the day.

3. The ostomy appliance according to claim 1, wherein said curved engagement surface of said front end at a rear end of said front portion is a contact edge for concentrating force radially disposed with said pivot shaft when said engagement ring is tension-free.

An ostomy appliance according to claim 2 or 3, characterized in that said wedge body is formed on said contact edge with a step and said contact edge is adapted to engage the surface of one of said side walls in said channel.

The ostomy appliance according to claim 4, wherein said surface of said one side wall is smooth and substantially cylindrical when said channel is unstretched.

6. An ostomy appliance according to claim 4, wherein said step is delimited by substantially right angle surfaces.

7. An ostomy appliance according to claim 1, wherein the wedge body is supported by said swivel shaft for pivotal movement ranging from about 2 to about 20 degrees about said axis of rotation. . 8. An ostomy appliance according to claim 1, wherein the maximum radial thickness of said wedge body substantially exceeds the maximum radial thickness of said sleeve.

The ostomy appliance according to claim 8, wherein said maximum radial thickness of said wedge body exceeds the combined maximum radial thickness of said sleeve and said shank. ·

10. The ostomy appliance of claim 1 wherein said wedge body is disposed radially inwardly

-1 o cbjímky * y onačený

The spike device according to claim 1, wherein said sleeve, swivel stem, and swivel wedge body are integrally formed of pelletized plastics,

A connecting ring for a two-part spike means, the ring comprising a substantially incompressible insertion means for inserting dc of an axial channel of a corresponding connection ring, said insert means comprising an axially oriented annular sleeve, an onion non-deformable ring-shaped body and an annular swivel stem connecting said bodies and sleeve in a concentric arrangement with a radial spacing, said onion body comprising a forward portion extending forwardly beyond said stem and a rear portion extending beyond said stem, said stem supporting said body for limited forward and backward movement about the axis of rotation, and said front. a portion of said body has a rearwardly curved engagement surface with a gradually increasing distance from said axis of rotation.

The coupling ring of claim 12 wherein said engagement curved surface extends rearwardly of said front portion and terminates in a contact edge for concentrating force along said rear portion. .14. A connecting ring according to claim 12, wherein said curved engagement surface terminates at a rear end of said front portion on a contact edge for concentrating force disposed with said stem when said second connecting ring of paradise is not energized.

Connecting ring according to claim 13 or 14, characterized in that a step is formed on said contact edge by said wedge body. ; -ý t,; . Connecting ring according to claim 15, characterized in that said step is defined by surfaces forming a substantially right angle.

Connecting ring according to claim 12, characterized in that said wedge-shaped body is supported by said swiveling ring. -akv ', 1 * -. -19- a pivot for a pivoting movement in the range of about 2 to about 20 degrees, and around it. 12. A coupling ring according to claim 12, wherein the maximum radial thickness of said wedge body? Essentially it exceeds the maximum radial thickness of the sleeve.

Connecting ring according to Claim 18, characterized in that said maximum radial thickness of said wedge body exceeds the combined maximum radial thickness of said sleeve and stem.

Connecting ring according to claim 12, characterized in that said wedge body is mounted radially within said sleeve.

Connecting ring according to claim 12, characterized in that said sleeve, the pivoting stem and the pivotable wedge body are integrally formed of a semi-rigid plastic grip. 'and'·. (, l, ··.; ···;) V

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